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The Sarns 9000 Universal Roller Pump is indicated for use in extracorporeal circulation of blood for arterial regional perfusion, and cardiopulmonary bypass procedures only, when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.

The Sarns 9000 Universal Roller Pump is a microprocessor controlled 2-roller peristaltic pump with adjustable occlusion. The pump is capable of flows up to 9.99 L/min (depending on pump head tubing used) at pump speeds up to 250 RPM. The Sarns 9000 Universal Roller Pump is dependent on the Sarns 9000 Perfusion System to provide power.

The provided text [0-3] does not contain information about acceptance criteria or a study proving device performance against such criteria. The document is a 510(k) summary for the Sarns 9000 Universal Roller Pump, detailing its substantial equivalence to a predicate device, technical characteristics, and intended use. It also lists safety and effectiveness issues reported for blood roller pumps in general, but does not present specific performance criteria or the results of testing the Sarns 9000 against them.

Therefore, I cannot provide the requested information.

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